| CTRI Number |
CTRI/2024/12/078659 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role Of Vishaghna Mahakashaya Ghnatvati And Vishaghna Lepa in Melasma |
|
Scientific Title of Study
|
A Study To Evaluate The Role Of Vishaghna Mahakashaya Ghanvati And Visaghna Lepa In Management Of Mukhshyavta W.S.R. To Melasma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Kumar Tiwari |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
room no 228 Dept of Agad tantra evum vidhi vaidhyak pt khushilal
sharma govt ayurveda college bhopal
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8770962368 |
| Fax |
|
| Email |
praveentiwari2804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Kumar Tiwari |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
room no 228 Dept of Agad tantra evum vidhi vaidhyak pt khushilal
sharma govt ayurveda college bhopal
Bhopal
MADHYA PRADESH
MADHYA PRADESH
462007
India |
| Phone |
8770962368 |
| Fax |
|
| Email |
praveentiwari2804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Kumar Tiwari |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
room no 228 Dept of Agad tantra evum vidhi vaidhyak pt khushilal
sharma govt ayurveda college bhopal
Bhopal
MADHYA PRADESH
MADHYA PRADESH
462007
India |
| Phone |
8770962368 |
| Fax |
|
| Email |
praveentiwari2804@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal sharma govt ayurveda college Bhopal 462003 m p india |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal sharma govt ayurveda college Bhopal |
| Address |
Nehru nagar kolar bypass behind MANIT Science hills Bhopal 462003 MP india |
| Type of Sponsor |
Other [ayurved medical collage and hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| praveen tiwari |
pt khushilal sharma govt hospital |
pt khushilal sharma
govt college an hospital
nehru nagar kolar
bypass near MANIT
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
8770962368
praveentiwari2804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vishaghna mahakashya ghan vati, Reference: charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sukhoshna jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | placebo | capsule filled with roasted semolina of 500 mg twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients having cardinal sign and symptoms of mukhshyavta (melasma)as in ayurvedic classics and contemporary science
diagnosed mild and moderate cases of melasma |
|
| ExclusionCriteria |
| Details |
patients having disease like urticaria with angioedema diabetes mellitus tuberculosis severe cardiac disease carcinoma
patients having major systemic illness
pregnant and lactating mothers will be excluded
patient without written consent form |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it is expected that at the end of study we would be able tp demonstrate the efficacy of vishaghna mahakashaya ghanvati and vishaghna lepa in the management of mukhshyavta |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is further expected that this study will be able
to provide information related to the safety of the
drug in the management of mukhshyavta |
12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
from this study,it is expected that we will be able to demonstrate the therapeutic effect of visaghna mahakashaya ghanvati along with external application of vishaghna lepa in mukhashyavata (melasma)
|